Letter From The CEO
Dear Fellow Shareholders,
We made significant progress in the second half of 2011 towards our goal of developing an innovative product pipeline for the diagnosis and treatment of misfolded protein diseases including neurodegenerative diseases such as ALS and Alzheimer's disease and cancer. Our strategy is to include the creation of strategic alliances and partnerships with companies that have complimentary capabilities, expertise and resources that will allow us to advance many more programs in parallel and maximize the potential of successfully bringing new products to market. Our partnerships with Biogen-Idec and PREVENT are advancing both the ALS antibody therapeutics and vaccine technology forward with little or no cost to Amorfix. Our most recent collaboration with Helix BioPharma combines the proprietary technologies of each company to produce a targeted cancer therapeutic that will be more effective at killing tumors while having fewer adverse side effects than traditional cancer therapies. As such, the Helix collaboration is another exciting addition to our partnerships. We will continue to establish key strategic alliances and partnerships in 2012 to accelerate development of our existing products as well as to add new products to our portfolio.
We have now identified antibodies from each of our three cancer programs that specifically bind to tumor cells and not normal tissue cells. This selectivity is the basis for our development of targeted therapeutics that will translate into new therapies that are much more effective and safer for the patients who take them. We are driving our programs forward towards establishing proof of concept of therapeutic activity in animal models of disease. This represents a major value inflection point for our cancer antibody programs and we are planning to achieve this in the first half of this year. In addition, we are actively seeking partners for our cancer programs as well as partners who may be interested in a ProMIS platform technology deal.
We have developed a unique system for the detection of the aggregated Abeta peptide, a recognized biomarker for AD and we recently announced that we achieved 85 percent specificity and sensitivity for the detection of aggregated Abeta in cerebrospinal fluid (CSF) of subjects with Alzheimer's disease and Mild Cognitive Impairment (MCI). The data suggest that the Amorfix test is superior for identification of patients with MCI when compared to the measurements of monomeric Abeta 1-42 alone. We see the utility of this assay as a means to dramatically improve the current state of AD diagnostics by improving clinicians' ability to properly identify patients with early stage disease and as a way to significantly improve the accuracy and reduce the time and cost of conducting clinical trials for development of new treatments for AD. We are now actively seeking a development partner to bring this important and valuable new asset to the market as quickly as possible.
We have signed a letter of intent with JSW-Lifesciences GmbH, a contract research organization specializing in Alzheimer's and other CNS diseases, to license our pre-clinical Alzheimer's disease diagnostic test, the Amorfix Aggregated Abeta Assay (the A4). JSW plans to add the A4 to its suite of preclinical research services provided to pharmaceutical companies and academic research institutions involved in Alzheimer's disease research and development. JSW is a large, successful CRO with a great reputation and solid experience in neurodegenerative diseases and the resources to create a significant market for the A4.
We recently announced a new program, the development of a diagnostic test for ALS. Initial ground breaking scientific study results from Amorfix Chief Scientific Officer Dr. Neil Cashman and colleagues at UBC demonstrate that misfolded SOD1 is present in the blood of ALS patients. We plan to capitalize on this discovery and existing scientific expertise to develop a simple blood test that measures misfolded SOD1 in blood. The Company has established key intellectual property around misfolded SOD1 and its potential role in neurodegenerative disease which covers the generation and use of any diagnostic, therapeutic or vaccine involving misfolded SOD1.
Finally, we are now in the process of raising sufficient cash to continue to advance our products to important program milestones and value inflection points. This, along with the formation of strategic partnerships, will allow us to continue to create value for our company and for our shareholders.
Thank you for your interest and support for Amorfix. I wish everyone a happy and prosperous new year.
Sincerely,
Robert Gundel, PhD, MBA
January 2012